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510(k) K102637

DYNAREX ULTRASOUND GEL by Dynarex Corporation — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2011
Date Received
September 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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